{"id":38221,"date":"2025-10-23T11:02:28","date_gmt":"2025-10-23T11:02:28","guid":{"rendered":"https:\/\/allonlinebanglanewspapers.com\/news\/tlx250-cdx-zircaix-included-in-leading-international-guidelines-for-renal-imaging\/"},"modified":"2025-10-23T11:02:28","modified_gmt":"2025-10-23T11:02:28","slug":"tlx250-cdx-zircaix-included-in-leading-international-guidelines-for-renal-imaging","status":"publish","type":"post","link":"https:\/\/allonlinebanglanewspapers.com\/news\/tlx250-cdx-zircaix-included-in-leading-international-guidelines-for-renal-imaging\/","title":{"rendered":"TLX250-CDx (Zircaix) Included in Leading International Guidelines for Renal Imaging"},"content":{"rendered":"
\n

MELBOURNE, Australia and INDIANAPOLIS, Oct. 23, 2025 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, \u201cTelix\u201d) today welcomes updated guidelines from the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the European Association of Nuclear Medicine (EANM) and The American College of Nuclear Medicine (ACNM) that, for the first time, include the use of Telix\u2019s investigational PET1<\/sup> agent, TLX250-CDx (Zircaix\u00ae2<\/sup>,\u00a089<\/sup>Zr-DFO-girentuximab), for molecular imaging of renal masses.<\/p>\n

Published on the SNMMI website3<\/sup> and in The Journal of Nuclear Medicine<\/em>4<\/sup>, the guideline panel5<\/sup>, comprising internationally renowned and multidisciplinary expert key opinion leaders, concludes that \u201cthe emerging use of molecular imaging for risk stratification of indeterminate renal masses offers the opportunity to more effectively characterize such lesions and optimize patient management decisions\u201d.<\/p>\n

The panel asserts that antibody-based radiotracers exhibit lower renal clearance, thereby improving visualization of renal masses. It emphasizes that TLX250-CDx PET \u201cappears to be a well-tolerated and accurate method for non-invasive identification of ccRCC6<\/sup>\u201d and notes by contrast, the high renal excretion with 18<\/sup>F-FDG PET, which obscures accurate lesion detection.<\/p>\n

The panel references data from Telix\u2019s pivotal Phase 3 ZIRCON trial7<\/sup>, which met all primary and secondary endpoints, demonstrating a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions8<\/sup>. TLX250-CDx works by specifically binding to carbonic anhydrase IX (CAIX), a validated target protein expressed on >95% of ccRCC cells9<\/sup>, to produce images with high tumor-to-background ratio and high intra- and inter-reader consistency.<\/p>\n

Professor Brian Shuch, MD, Director of the Kidney Cancer Program and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research at UCLA Institute of Urologic Oncology and guideline author, commented, \u201cThe recognition of 89<\/sup>Zr-girentuximab PET in the SNMMI\/EANM\/ACNM clinical guidelines reflects a shift toward precision medicine in renal cancer, providing clinicians with a more accurate tool for diagnosis to guide optimal, individualized treatment planning for patients.\u201d<\/p>\n

Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, added, \u201cThe inclusion of TLX250-CDx PET imaging for the first time in SNMMI\/EANM\/ACNM guidelines is an important development for Telix and will help raise awareness of this breakthrough precision diagnostic. Subject to regulatory approval, endorsement by this expert global multidisciplinary panel will help to drive adoption and implementation into clinical workflows, supporting clinical utility and enhancing decision-making to improve patient outcomes.\u201d<\/p>\n

SNMMI, EANM and ACNM periodically define new procedure standards\/guidelines to help advance the science of nuclear medicine and to improve the quality of service to patients. Each standard\/guideline, representing a policy statement by these groups undergoes a thorough consensus process in which it has been subjected to extensive review.<\/p>\n

About TLX250-CDx<\/strong><\/p>\n

TLX250-CDx is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix\u2019s pivotal Phase 3 ZIRCON trial evaluating TLX250-CDx in 300\u202fpatients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% PPV for ccRCC across three independent radiology readers. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC.<\/p>\n

For more on TLX250-CDx and Telix\u2019s theranostic kidney cancer program, click\u00a0here<\/a>.\u00a0
TLX250-CDx has not received a marketing authorization in any jurisdiction.<\/p>\n

About <\/strong>Telix Pharmaceuticals Limited <\/strong><\/p>\n

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).<\/p>\n

Illuccix\u00ae (kit for the preparation of gallium-68 (68<\/sup>Ga) gozetotide injection), Telix\u2019s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix\u00ae (kit for the preparation of gallium-68 (68<\/sup>Ga) gozetotide injection) has been approved by the U.S. FDA10<\/sup>.<\/p>\n

Visit www.telixpharma.com<\/a> for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn<\/a>, X<\/a> and Facebook<\/a><\/p>\n

Telix Investor Relations (Global)<\/strong><\/p>\n

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com<\/a><\/p>\n

Telix Investor Relations (U.S.)\u202f\u00a0<\/strong><\/p>\n

Annie Kasparian\u202f\u00a0
Telix Pharmaceuticals Limited\u202f\u00a0
Director Investor Relations and Corporate Communications\u202f\u00a0
Email: annie.kasparian@telixpharma.com<\/a>\u00a0<\/p>\n

Media Contact<\/strong><\/p>\n

Eliza Schleifstein
Eliza@schleifsteinpr.com<\/a><\/p>\n

Legal Notices<\/p>\n

Cautionary Statement Regarding Forward-Looking Statements.\u00a0 <\/em><\/p>\n

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.<\/em><\/p>\n

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. \u202fTo the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.<\/em><\/p>\n

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as \u201cmay\u201d, \u201cexpect\u201d, \u201cintend\u201d, \u201cplan\u201d, \u201cestimate\u201d, \u201canticipate\u201d, \u201cbelieve\u201d, \u201coutlook\u201d, \u201cforecast\u201d and \u201cguidance\u201d, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix\u2019s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix\u2019s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix\u2019s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix\u2019s preclinical and clinical trials, and Telix\u2019s research and development programs; Telix\u2019s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix\u2019s product candidates, manufacturing activities and product marketing activities; Telix\u2019s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix\u2019s product candidates, if or when they have been approved; Telix\u2019s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix\u2019s expenses, future revenues and capital requirements; Telix\u2019s financial performance; developments relating to Telix\u2019s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix\u2019s business; and the pricing and reimbursement of Telix\u2019s product candidates, if and after they have been approved. Telix\u2019s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.<\/em><\/p>\n

Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the \u00ae or \u2122 symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties.<\/em><\/p>\n

\u00a92025 Telix Pharmaceuticals Limited. All rights reserved.<\/em><\/p>\n

1<\/sup> Positron emission tomography.
2<\/sup> Brand name subject to final regulatory approval.
3<\/sup> https:\/\/snmmi.org\/common\/Uploaded%20files\/Web\/Clinical%20Practice\/Procedure%20Standards\/2025\/SNMMI_EANM_ACNM_Renal_Masses-Final%20JNM%20sumbission.pdf
4<\/sup> SNMMI\/EANM\/ACNM Procedure Standard\/Procedure Guideline on the Use of Molecular Imaging for Renal Mass Characterization (October 2025), available at: https:\/\/jnm.snmjournals.org\/content\/early\/2025\/10\/09\/jnumed.125.271332.abstract
5<\/sup> Steven P. Rowe, Brian M. Shuch, Mark W. Ball, Axel Bex, Mehrbod S. Javadi, Alan Klitzke, Karolien Goffin,\u00a0Peter Mulders, Neeta Pandit-Taskar, Ashwin Singh Parihar, Benjamin L. Viglianti, Michael A. Gorin, and\u00a0Ken Herrmann.
6<\/sup> Clear cell renal cell carcinoma, the most common and one of the most aggressive subtypes of kidney cancer.
7<\/sup> ClinicalTrials.gov ID:\u00a0NCT03849118<\/a>.
8<\/sup> Telix ASX disclosures 7 November 2022. Shuch et al.\u00a0Lancet Oncology.<\/em>\u00a02024.
9<\/sup> Stillebroer et al. Eur Urol<\/em>. 2010.
10<\/sup> Telix ASX disclosure 21 March 2025.<\/p>\n

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MELBOURNE, Australia and INDIANAPOLIS, Oct. 23, 2025 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, \u201cTelix\u201d) today welcomes updated guidelines from the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the European Association of Nuclear Medicine (EANM) and The American College of Nuclear Medicine (ACNM) that, for the first time, include the use 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